TOPTAM V1.0
Research type
Research Study
Full title
A double-blind placebo controlled phase 2 clinical trial to assess the effects of topical Tamoxifen on the promotion of diabetic foot ulcer healing
IRAS ID
84406
Contact name
Matthew Hardman
Contact email
Sponsor organisation
Central Manchester and Manchester University Hospitals NHS Foundation Trust
Eudract number
2014-003564-20
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Chronic non-healing skin ulcers, widespread in the elderly and diabetic populations, represent a major area of unmet clinical need. Current treatments are largely ineffective as underlying mechanisms that lead to non-healing are not fully understood. Previous studies by Dr Hardman’s team have demonstrated a key role for estrogen deficiency in delayed healing in elderly men and women and the potential for selective estrogen receptor modulators (SERMs) to promote skin wound repair.
The primary objective of this blinded randomised placebo controlled study is to test direct topical application of the first-generation SERM tamoxifen, currently in widespread clinical use, to promote healing of diabetic foot ulcers (DFUs) in both male and post-menopausal female human patients. It is hypothesised that topical administration of tamoxifen will provide a favourable alternative to existing interventions which concentrate on prevention of secondary complications such as infection.
A total of 90 eligible subjects will be randomised in a 1:1:1 ratio to receive either tamoxifen or estrogen or placebo. Treatments will be administered during routine clinic visits weekly during the first 6 weeks of the study in addition to current best practice treatment for the 12 week duration of the study. Clinical assessments will be performed and healing progression examined weekly for the duration of the study.
Primary response to treatment will be determined by wound area reduction. Secondary objectives include assessment of biopsy samples regarding histological and cellular profiles of the healing wound at the beginning and end of treatment. Blood samples will be used to monitor systemic hormone levels in response to treatment.
Safety assessment will be performed throughout, including biochemistry and adverse events.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0391
Date of REC Opinion
19 May 2015
REC opinion
Favourable Opinion